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The FDA has stated that its preliminary review of the BLA has not identified any potential review issues with the filing at the current time and it has also determined that as glucarpidase has orphan drug designation it is exempt from pediatric assessments.

Glucarpidase is an experimental treatment for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function. High dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain types of cancer such as leukaemia, lymphoma and osteosarcoma. Patients may be considered at risk of methotrexate toxicity if either they have impaired renal function, which can lead to a delay in elimination from the body or if they have evidence of delayed elimination. Glucarpidase is not yet approved in any country. Glucarpidase is currently available in the US under an expanded access IND and cost recovery programme and in selected countries outside the US on a named patient basis.

About BTG
BTG (btgplc.com) is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products.

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